Importance of TKI treatment duration in treatment-free remission of chronic myeloid leukemia: results of the D-FREE study.

Autor: Yoshida C; Department of Hematology, National Hospital Organization Mito Medical Center, 280 Sakuranosato, Ibarakimachi, Higashiibarakigun, Ibaraki, 311-3193, Japan. c.yoshida@mitomedical.org., Yamaguchi H; Department of Hematology, Nippon Medical School, Tokyo, Japan., Doki N; Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan., Murai K; Department of Hematology, Iwate Prefectural Central Hospital, Morioka, Japan., Iino M; Department of Medical Oncology, Yamanashi Prefectural Central Hospital, Kofu, Japan., Hatta Y; Division of Hematology and Rheumatology, Nihon University School of Medicine, Tokyo, Japan., Onizuka M; Department of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan., Yokose N; Department of Hematology, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan., Fujimaki K; Department of Hematology, Fujisawa City Hospital, Fujisawa, Japan., Hagihara M; Department of Hematology, EIJU General Hospital, Taito-Ku, Japan., Oshikawa G; Japanese Red Cross Musashino Hospital, Musashino, Japan., Murayama K; Division of Hematology, Gunma Prefectural Cancer Center, Ohta, Japan., Kumagai T; Department of Hematology, Ome Municipal General Hospital, Ome-Shi, Tokyo, Japan., Kimura S; Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan., Najima Y; Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan., Iriyama N; Division of Hematology and Rheumatology, Nihon University School of Medicine, Tokyo, Japan., Tsutsumi I; Department of Hematology, National Hospital Organization Mito Medical Center, 280 Sakuranosato, Ibarakimachi, Higashiibarakigun, Ibaraki, 311-3193, Japan., Oba K; Department of Biostatistics, The University of Tokyo, Tokyo, Japan., Kojima H; Ibaraki Clinical Education and Training Center, University of Tsukuba Hospital, Kasama, Japan., Sakamaki H; Hematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan., Inokuchi K; Department of Hematology, Nippon Medical School, Tokyo, Japan.
Jazyk: angličtina
Zdroj: International journal of hematology [Int J Hematol] 2023 May; Vol. 117 (5), pp. 694-705. Date of Electronic Publication: 2023 Feb 04.
DOI: 10.1007/s12185-023-03549-3
Abstrakt: Treatment-free remission (TFR) is a new goal for patients with chronic myeloid leukemia in chronic phase (CML-CP) with a sustained deep molecular response (DMR) to treatment with tyrosine kinase inhibitors (TKIs). However, optimal conditions for successful TFR in patients treated with second-generation (2G)-TKIs are not fully defined. In this D-FREE study, treatment discontinuation was attempted in newly diagnosed CML-CP patients treated with the 2G-TKI dasatinib who achieved BCR-ABL1 levels of ≤ 0.0032% (MR4.5) on the international scale (BCR-ABL1 IS ) and maintained these levels for exactly 1 year. Of the 173 patients who received dasatinib induction therapy for up to 2 years, 123 completed and 60 (48.8%) reached MR 4.5. Among the first 21 patients who maintained MR4.5 for 1 year and discontinued dasatinib, 17 experienced molecular relapse defined as loss of major molecular response (BCR-ABL1 IS  > 0.1%) confirmed once, or loss of MR4 (BCR-ABL1 IS  > 0.01%) confirmed on 2 consecutive assessments. The estimated molecular relapse-free survival rate was 16.7% at 12 months. This study was prematurely terminated according to the protocol's safety monitoring criteria. The conclusion was that sustained DMR for just 1 year is insufficient for TFR in CML-CP patients receiving dasatinib for less than a total of 3 years of treatment.
(© 2023. The Author(s).)
Databáze: MEDLINE
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